Land: Malta
Taal: Engels
Bron: Medicines Authority
Viatris Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
R03BB04
TIOTROPIUM BROMIDE 18 µg
INHALATION POWDER HARD CAPSULE
TIOTROPIUM BROMIDE 18 µg
POM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
Authorised
2019-06-25
Page 1 of 10 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Sirkava 18 microgram, inhalation powder, hard capsule tiotropium READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, or pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor , or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Sirkava is and what it is used for 2. What you need to know before you use Sirkava 18 microgram 3. How to use Sirkava 18 microgram 4. Possible side effects 5. How to store Sirkava 18 microgram 6. Contents of the pack and other information 1. WHAT SIRKAVA IS AND WHAT IT IS USED FOR Sirkava 18 microgram helps people who have chronic obstructive pulmonary disease (COPD) to breathe more easily. COPD is a chronic lung disease that causes shortness of breath and coughing. The term COPD is associated with the conditions chronic bronchitis and emphysema. As COPD is a chronic disease you should take Sirkava 18 microgram every day and not only when you have breathing problems or other symptoms of COPD. Sirkava 18 microgram is a long-acting bronchodilator that helps to open your airways and makes it easier to get air in and out of the lungs. Regular use of Sirkava 18 microgram can also help you when you have on- going shortness of breath related to your disease and will help you to minimise the effects of the disease on your everyday life. It also helps you to be active longer. Daily use of Sirkava 18 microgram will also help to prevent sudden, short-term worsening of your COPD symptoms which may last for several days. The effect of this medicine lasts for 24 hours, so you only need to use it once a day. For correct do Lees het volledige document
Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Sirkava 18 microgram, inhalation powder, hard capsule 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 21.7 microgram tiotropium bromide anhydrous equivalent to 18 microgram tiotropium. The delivered dose (the dose that leaves the mouthpiece of the NeumoHaler device) is 12 microgram tiotropium. Excipient with known effect Each capsule contains 5.5 mg of lactose anhydrous For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Inhalation powder, hard capsule. White or almost white capsules marked with T18 in black ink on the cap containing white or almost white powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tiotropium is indicated as a maintenance bronchodilator treatment to relieve symptoms of patients with chronic obstructive pulmonary disease (COPD). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The medicinal product is intended for inhalation use only. The recommended dosage of tiotropium bromide is inhalation of the contents of one capsule once daily with the NeumoHaler device at the same time of day. The recommended dose should not be exceeded. Tiotropium bromide capsules are only for inhalation and not for oral intake. Tiotropium bromide capsules must not be swallowed. Tiotropium bromide should only be inhaled with the NeumoHaler device. Special populations Geriatric patients can use tiotropium bromide at the recommended dose. Renally impaired patients can use tiotropium bromide at the recommended dose. For patients with moderate to severe impairment (creatinine clearance ≤ 50 ml/min) see section 4.4 and section 5.2. Page 2 of 16 Hepatically impaired patients can use tiotropium bromide at the recommended dose (see section 5.2). Paediatric population _COPD _ There is no relevant use in the paediatric population (below 18 years) in the indication stated under section 4.1. _Cystic fibrosis _ The safety and efficacy of Sirkava 18 microgram in children and adolescents has not bee Lees het volledige document